SPARTAN S3 FACET SYSTEM

K113011 · Amendia, Inc. · MRW · Dec 6, 2011 · OR

Device Facts

• Record ID: K113011
• Device Name: SPARTAN S3 FACET SYSTEM
• Applicant: Amendia, Inc.
• Product Code: MRW · OR
• Decision Date: Dec 6, 2011
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Spartan S3 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations: 2) Spondylolisthesis; 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: 4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability. The Spartan S Facet System will provide temporary stabilization as an adjunct to spinal fusion.

Device Story

The Spartan S³ Facet System is a permanent titanium alloy (TI 6AL4V-ELI) implant designed for posterior spinal stabilization. It consists of screws available in multiple diameters and lengths, featuring a swivel washer and screw skirt to allow 360° orientation for optimal placement. Used by surgeons in an operating room setting, the device provides mechanical support and temporary stabilization as an adjunct to spinal fusion until biologic fusion is achieved. It addresses spinal instability caused by trauma, degenerative disease, or failed prior surgeries.

Clinical Evidence

Bench testing only. Static and dynamic cantilever bend tests were performed in accordance with ASTM F2193-02 to evaluate the mechanical integrity of the device with and without the swivel washer and skirt. Results confirmed the device is substantially equivalent to predicate devices.

Technological Characteristics

Material: Titanium alloy TI 6AL4V-ELI. Design: Posterior spinal screw system with swivel washer and screw skirt. Connectivity: None. Sterilization: Not specified. Testing standard: ASTM F2193-02 (static/dynamic cantilever bend).

Indications for Use

Indicated for patients requiring posterior spinal stabilization at levels C2-S1 for trauma (fractures/dislocations), spondylolisthesis, pseudoarthrosis, failed previous fusions, or degenerative diseases (DDD or facet instability).

Predicate Devices

• Spartan S2 Facet Screw System (K092568)
• Lanx Concero Facet Screw System (K101364)
• DISCOVERY Facet Screw (K012773)
• Triad Facet Screw System (K020411)
• Oasys Bone Screw (K031657)
• Trans1 Facet Screw (K073515)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary according to 807.92(c)

| Date: | November 18, 2011 |
|-----------------|-------------------------|
| Contact: | Tim Lusby |
| | Amendia™, INC |
| | 1755 W. Oak Parkway |
| | Marietta, GA 30062 |
| | 770-874-0935 |
| Trade Name: | Spartan S³ Facet System |
| Classification: | Unclassified |
| Product Codes: | MRW |
| Panel Code: | 87 |

Indications for Use: The Spartan S3 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

- 1) Trauma, including spinal fractures and/or dislocations:
- 2) Spondylolisthesis;

3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity:

4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S Facet System will provide temporary stabilization as an adjunct to spinal fusion.

The Spartan S Facet System is a permanent implant device made from a titanium Device Description: alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. This submission ads a swivel washer and screw skirt to the 5mm diameter screw. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

Technological Characteristics: The Spartan S Facet System has technological characteristics similar to the predicate devices. Screw sizes, materials, and use of a swivel washer and screw skirt. The swivel washer for both systems allows the screw to be directed 360° to accommodate optimal screw placement. The indications for use are the same for both systems.

The predicate devices previously cleared by FDA are the previously cleared Predicate Device(s): Spartan S2 Facet Screw System (K092568), the Lanx Concero Facet Screw System (K101364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K020411), Oasys Bone Screw (K031657) and the Trans1 Facet Screw (K073515).

Performance Testing: The pre-clinical testing was performed following ASTM F2193-02. Testing consisted of static and dynamic cantilever bend tests with and without the swivel washer and skirt. The test results indicate that the Spartan S Facet System is substantially equivalent to the predicate devices and is adequate for the intended use.

Conclusion: Amendia concludes that the data provided demonstrates substantial equivalence to the predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC - 6 2011

Amendia, Inc. % Silver Pine Consulting. LLC Rich Jansen, Pharm. D. 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K113011

Trade/Device Name: Spartan S Facet System Regulation Number: Unclassified Product Code: MR W Dated: November 18. 2011 Received: November 18, 2011

Dear Dr. Jansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may . publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

{2}------------------------------------------------

Page 2 - Rich Jansen. Pharm. D.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification". (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

ly yours,

Fife

L. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Amendia 510(k)

## Statement of Indications for Use

510(k) Number (if known): KII 301

The Spartan S Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

l ) Trauma, including spinal fractures and/or dislocations;

2) Spondylolisthesis:

3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity:

4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Diyslon of Surgical, Orthopedic, dic, and Restorative Devices

Pg l of

KI:3011